The screening for latent tuberculosis infection (LTBI) prior to the onset of anti-tumor necrosis factor therapy, as well as a watchful monitoring during the treatment, is strongly recommended. Tuberculin skin test (TST), universally used for this purpose, lacks sensitivity and specificity. The novel screening tools, including QuantiFERON-TB Gold In-Tube (QFT-GIT), have shown a higher specificity compared to TST, but their feasibility in the setting of immunosuppression remains unclear. Aims of this study were to investigate the performance of QFT-GIT and its agreement with TST in patients awaiting anti-tumor necrosis factor (TNF) therapy, and to evaluate the usefulness of serial QFT-GIT during the treatment with biologics to assess whether dynamic changes in interferon (IFN)-gamma levels may be helpful in identifying reactivation of LTBI or cases of newly acquired tuberculosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
119
Patients were randomized to undergo, on the same day, TST and QFT-GIT by means of a randomization list to generate the order by which the 2 tests had to be executed. QFT-GIT was repeated after 3 and 6 months since TNF antagonist onset
Change from baseline in IFN-gamma plasma levels following serial QFT-GIT testing during the treatment with anti-TNF agents
QFT-GIT was performed at randomization (before commencement of anti-TNF treatment) and after 3 and 6 months since the beginning of biologicals.
Time frame: From date of randomization (before anti-TNF treatment) until the date of repeated QFT-GIT testing (after 12 weeks and again after 24 weeks) for a total assessment of 7 months.
Performance of QFT-GIT and its agreement with TST in patients under consideration for anti-TNF agents
QFT-GIT and TST were performed at baseline, before the commencement of anti-TNF treatment.
Time frame: From date of randomization (before anti-TNF treatment) until the date of acquisition of QFT-GIT and TST results, for a total of 1 month.
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